南京健友生化制药股份有限公司 关于子公司获得美国FDA来法莫林注射液药品生产场地转移注册批件的公告

Group 1 - The company has received FDA approval for the production site transfer of Lefamulin Injection, 150 mg/15 mL, to its subsidiary, Jianjin Pharmaceutical Co., Ltd. [1][2] - Lefamulin Injection, marketed as XENLETA, was originally approved by the FDA in August 2019 and is currently not available as a generic in the U.S. market [1][6] - The company has invested approximately RMB 19.33 million in the research and development of the Lefamulin production site transfer project [2] Group 2 - The approval of this product enhances the company's international product pipeline and strengthens its market presence [3] - If the product progresses to market sales in the U.S., it is expected to have a positive impact on the company's operating performance [3]